Yesterday, the Department of Health and Human Services moved to allow compounding of six peptides while formal rulemaking is underway, following the recommendation of its Pharmacy Compounding Advisory Committee (PCAC) this summer. This draft interim policy is meaningful progress toward a regulated, safer pathway to care. As more Americans seek these treatments, regulated channels, clinician oversight, quality standards, and transparency are critical, and none of them exist in today’s gray market.
At Hims & Hers, our goal has always been to define what responsible access to care in this specialty looks like. We’ve spent years building the infrastructure we need in our very own U.S.-based peptide manufacturing facility, developing dosing protocols with leading clinical experts, and setting up frameworks to better understand the potential benefits and possible side effects of these emerging treatments.
Today, people can preview Peptides+, our new specialty built around a clinically guided protocol that targets health and wellness at a cellular level. Peptides+ is designed to support each individual’s unique, ever-changing biology. Eligible Hims & Hers customers can access peptides and other therapies that emerging research is exploring for a range of needs, from energy and recovery to cognitive clarity and cellular resilience. We plan to offer access to Sermorelin, Glutathione, B12, NAD+, and L-carnitine, with BPC-157 and TB-500 to follow when allowable. If a customer is eligible, a personalized treatment plan will be prescribed and delivered by independent providers, treatments supplied by licensed pharmacies, with ongoing clinical support our customers can trust. Learn more and join the list to be among the first in line when we launch Peptides+ for Hims & Hers.
We’re focused on entering this specialty the right way, not the fastest. Most of what we know about these compounds is still early — with limited published studies, we draw primarily from clinical experience from the last decade. We’ve consistently acknowledged that while these compounds hold promise, there is still information we do not yet know. Provider-supervised use is how we plan to build on this foundation and make sure that access and innovation can move at the same pace.
We'll keep working to bring these treatments within reach of those who need them, and keep refining as we learn, including when the FDA convenes the next PCAC to weigh five more peptides for compounding. Done right, this could mean a real, meaningful difference in how people feel in their own bodies, and that's worth the time it takes to get there.
Cautionary Note Regarding Forward Looking Statements
This communication includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by the use of forward-looking terminology, including the words "anticipates," "expects," "intends," "plans," "decides," "may," "will," "likely," "potential," "future," "coming," "hope," or "should," or, in each case, their negative or other variations or comparable terminology. There can be no assurance that actual results will not materially differ from expectations. Such statements include, but are not limited to, the HHS’ draft interim policy regarding peptide compounding and its potential effects on access to peptide therapies; our planned peptide specialty, including the treatments we expect to offer, the timing and availability of their launch, and the potential effects of these offerings on customers and our business; and the potential outcome of future Pharmacy Compounding Advisory Committee review of additional peptides. These statements are based on management's current expectations, but actual results may differ materially due to various factors.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, the forward-looking statements contained in this communication are based on our current expectations, assumptions and beliefs concerning future developments and their potential effects on us. Future developments affecting us may not be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the timing and logistical considerations related to the launch and broader rollout of Peptides+ and the treatments available through it, and the related customer response; the limited clinical data available on peptide therapies, including their safety and efficacy and the possibility of side effects that are not yet known; our ability to operate our U.S.-based peptide manufacturing facility and our reliance on independent providers and licensed pharmacies; the timing or feasibility of expanded access to additional treatment options, including BPC-157 and TB-500; changes in HHS’s draft interim policy or the final outcome of rulemaking; changes in the application, interpretation, and enforcement of healthcare, compounding, consumer protection or privacy laws or regulations applicable to our business, including future HHS, FDA, and Pharmacy Compounding Advisory Committee actions relating to peptides; and other factors described in the Risk Factors and other sections of our most recently filed Quarterly Report on Form 10-Q, our most recently filed Annual Report on Form 10-K, and other current and periodic reports we file from time to time with the Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. The forward-looking statements contained in this communication are made only as of October 29, 2026. We undertake no obligation (and expressly disclaim any obligation) to update or revise any forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from those made in or suggested by the forward-looking statements contained in this communication.
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